Chronic Obstructive Pulmonary Disease (COPD)Phase 3TITANIANCT05158387

Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations.

A Phase 3 study testing Tozorakimab in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 212 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 130 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: Tozorakimab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,172 participants
Where: 212 sitesin 20 countries
Study dates: 7 Feb 2022to 22 Mar 2026
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant must be ≥ 40 years of age and capable of giving signed informed consent.
Documented diagnosis of COPD for at least one year prior to enrolment.
Post BD FEV1/FVC < 0.70 and post-BD FEV1 >20% of predicted normal value.
Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
Documented optimized inhaled dual or triple therapy at a stable dose for at least 3 months prior to enrolment.
Smoking history of ≥ 10 pack-years.
CAT total score ≥10, with each of the phlegm (sputum) and cough items with a score ≥ 2

Who cannot join

Clinically important pulmonary disease other than COPD.
Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms.
Current diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18.
Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment that could affect safety, study findings or participants ability to complete the study.
COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization.
Active significant infection within the 4 weeks prior to randomization, pneumonia within 6 weeks prior to randomization, or medical condition that predisposes the participant to infection.

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Suspicion of, or confirmed, ongoing SARS-CoV-2 infection.
Significant COVID-19 illness within the 6 months prior to enrolment.
Unstable cardiovascular disorder.
Diagnosis of cor pulmonale, pulmonary arterial hypertension and/or right ventricular failure.
History of known immunodeficiency disorder, including a positive test for HIV-1 or HIV 2.
History of positive test or treatment for hepatitis B or hepatitis C (except for cured hepatitis C)
Evidence of active liver disease, including jaundice during screening.
Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than one year prior to enrolment. Suspected malignancy or undefined neoplasms.
Participants who have evidence of active TB.
Participants that have previously received tozorakimab.
Any clinically significant abnormal findings in physical examination, vital signs, ECG, or laboratory testing during the screening period, which in the opinion of the investigator may put the participant at risk because of their participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.
Active vaping of any products or using smoked marijuana within the 6 months prior to randomization and during the study.

Trial locations and contacts

212 sites in 20 countries.

Country

City, postcode or hospital

212 sites in 20 countries

China43 sites

Research Site
Baotou, 014010
Research Site
Beijing, 100144
Research Site
Beijing, 101200
Research Site
Changchun, 130021
Research Site
Changde, 415000
Research Site
Changsha, 410015
Research Site
Chengdu, 610000
Research Site
Chengdu, 610031
Research Site
Chengdu, 610083
Research Site
Chongqing, 400013
Research Site
Chongqing, 400037
Research Site
Guangzhou, 510120
Research Site
Guangzhou, 510180
Research Site
Guangzhou, 510630
Research Site
Haikou, 570311
Research Site
Hangzhou, 310006
Research Site
Hefei, 230001
Research Site
Hohhot, 010010
Research Site
Kunming, 650032
Research Site
Linhai, 317000
Research Site
Nanchang, 330006
Research Site
Nanjing, 210006
Research Site
Ningbo, 315010
Research Site
Shanghai, 200002
Research Site
Shanghai, 200433
Research Site
Shanghai, 201199
Research Site
Shengyang, 110004
Research Site
Shenyang, 110016
Research Site
Shenzhen, 518020
Research Site
Shenzhen, 518053
Research Site
Shijiazhuang, 50051
Research Site
Suzhou, 215002
Research Site
Taiyuan, 030001
Research Site
Tianjin, 300050
Research Site
Wuhan, 430022
Research Site
Wuxi, 214023
Research Site
Xiamen, 361004
Research Site
Xuzhou, 221000
Research Site
Xuzhou, 221009
Research Site
Yangzhou, 225001
Research Site
Yinchuan, 750004
Research Site
Zhanjiang, 524004
Research Site
Zunyi, 563100

Other trials in China

United States34 sites

Research Site
Amarillo, Texas, 79106
Research Site
Ann Arbor, Michigan, 48109
Research Site
Bay Pines, Florida, 33744
Research Site
Boerne, Texas, 78006
Research Site
Bowling Green, Kentucky, 42101
Research Site
Buffalo, New York, 14203
Research Site
Cape Coral, Florida, 33990
Research Site
Colorado Springs, Colorado, 80909
Research Site
Cudahy, Wisconsin, 53110
Research Site
Farmington Hills, Michigan, 48336
Research Site
Fort Worth, Texas, 76104
Research Site
Grand Rapids, Michigan, 49546
Research Site
Greenwood, Indiana, 46143
Research Site
Lincoln, California, 95648
Research Site
Macon, Georgia, 31201
Research Site
McKinney, Texas, 75069
Research Site
Newark, Delaware, 19713
Research Site
Newport Beach, California, 92663
Research Site
North Dartmouth, Massachusetts, 02747
Research Site
Northridge, California, 91324
Research Site
Oklahoma City, Oklahoma, 73104
Research Site
Pensacola, Florida, 32503
Research Site
Philadelphia, Pennsylvania, 19140
Research Site
Rock Hill, South Carolina, 29732
Research Site
Sheffield, Alabama, 35660
Research Site
Tampa, Florida, 33607
Research Site
The Bronx, New York, 10459
Research Site
Toledo, Ohio, 43617
Research Site
Tomball, Texas, 77375
Research Site
Tulsa, Oklahoma, 74133
Research Site
Webster, Texas, 77598
Research Site
White Marsh, Maryland, 21162
Research Site
Williamsburg, Virginia, 23188
Research Site
Winter Park, Florida, 32789

Other trials in United States

Poland15 sites

Research Site
Bialystok, 15-044
Research Site
Bialystok, 15-704
Research Site
Bychawa, 23100
Research Site
Bydgoszcz, 85-796
Research Site
Katowice, 40-648
Research Site
Krakow, 30-033
Research Site
Lublin, 20-412
Research Site
Ostróda, 14-100
Research Site
Ostrowiec Świętokrzyski, 27-400
Research Site
Poznan, 60-693
Research Site
Poznan, 61-578
Research Site
Rzeszów, 35-205
Research Site
Skierniewice, 96-100
Research Site
Sosnowiec, 41-208
Research Site
Wroclaw, 53-301

Other trials in Poland

Italy14 sites

Research Site
Bari, 70124
Research Site
Massa, 54100
Research Site
Milan, 20142
Research Site
Milan, 20157
Research Site
Naples, 80131
Research Site
Roma, 00168
Research Site
Salerno, 84131
Research Site
San Donà di Piave, 30027
Research Site
Sassari, 07100
Research Site
Statte, 74010
Research Site
Telese Terme, 82037
Research Site
Tradate, 21049
Research Site
Vercelli, 13100
Research Site
Verona, 37134

Other trials in Italy

Brazil12 sites

Research Site
Blumenau, 89030-101
Research Site
Botucatu, 18618-686
Research Site
Brasília, 71681-603
Research Site
Curitiba, 80440-220
Research Site
Porto Alegre, 90035074
Research Site
Porto Alegre, 9061-000
Research Site
Porto Alegre, 91010-006
Research Site
Rio de Janeiro, 22061-080
Research Site
São Bernardo do Campo, 09750-420
Research Site
São Paulo, 01323-903
Research Site
São Paulo, 01409-001
Research Site
São Paulo, 05403-000

Other trials in Brazil

Germany11 sites

Research Site
Ahrensburg, 22926
Research Site
Bamberg, 96049
Research Site
Berlin, 10717
Research Site
Berlin, 12157
Research Site
Cologne, 51069
Research Site
Darmstadt, 64283
Research Site
Halle, 6108
Research Site
Marburg, 35037
Research Site
München, 80336
Research Site
München-Pasing, 81241
Research Site
Peine, 31224

Other trials in Germany

France10 sites

Research Site
Brest, 29609
Research Site
Dijon, 21079
Research Site
Grenoble, 38043
Research Site
Lyon, 69317
Research Site
Marseille, 13915
Research Site
Montivilliers, 76290
Research Site
Montpellier, 34090
Research Site
Pessac, 33604
Research Site
Saint-Herblain, 44093
Research Site
Toulouse, 31059

Other trials in France

Australia9 sites

Research Site
Campbelltown, 2560
Research Site
Frankstown, 3199
Research Site
Macquarie University, 2109
Research Site
Melbourne, 3000
Research Site
Nedlands, 6009
Research Site
Southport, 4215
Research Site
Spearwood, 6163
Research Site
Wollongong, 2500
Research Site
Woodville South, 5011

Other trials in Australia

Taiwan9 sites

Research Site
Hsinchu, 300
Research Site
Kaohsiung City, 807
Research Site
Kaohsiung City, 82445
Research Site
Taichung, 40443
Research Site
Taichung, 40705
Research Site
Taipei, 100
Research Site
Taipei, 110
Research Site
Taoyuan, 333
Research Site
Yunlin, 640

Other trials in Taiwan

United Kingdom9 sites

Research Site
Bradford, BD9 6RJ
Research Site
Corby, NN17 2UR
Research Site
Corby, NN18 9EZ
Research Site
Enfield, EN3 4GS
Research Site
Hampshire, SO16 6YD
Research Site
High Wycombe, HP11 2QW
Research Site
Northwood, HA6 2RN
Research Site
Preston, PR2 9QB
Research Site
Shipley, BD18 3SA

Other trials in United Kingdom

Thailand8 sites

Research Site
Bang Kra So, 11000
Research Site
Bangkok, 10700
Research Site
Hat Yai, 90110
Research Site
Khon Kaen, 40002
Research Site
Muang, 22000
Research Site
Muang,, 55000
Research Site
Mueang, 20000
Research Site
Nakhon Ratchasima, 30000

Other trials in Thailand

Chile7 sites

Research Site
Curicó, 3341643
Research Site
Santiago, 7500010
Research Site
Santiago, 7500657
Research Site
Santiago, 7500698
Research Site
Santiago, 8150000
Research Site
Santiago, 8241479
Research Site
Talca, 3465584

Other trials in Chile

Greece6 sites

Research Site
Alexandroupoli, 68100
Research Site
Athens, 11527
Research Site
Exohi Thessaloniki, 57010
Research Site
Ioannina, 45500
Research Site
Pátrai, 26500
Research Site
Thessaloniki, 57010

Other trials in Greece

Israel6 sites

Research Site
Ashkelon, 78278
Research Site
Beersheba, 8410101
Research Site
Jerusalem, 9372212
Research Site
Kfar Saba, 4428164
Research Site
Rehovot, 76100
Research Site
Tel Aviv, 6423906

Other trials in Israel

Romania5 sites

Research Site
Brasov, 500283
Research Site
Bucharest, 050159
Research Site
Cluj-Napoca, 400371
Research Site
Constanța, 900002
Research Site
Timișoara, 300002

Other trials in Romania

Colombia4 sites

Research Site
Barranquilla, 80007
Research Site
Ibague, 730006
Research Site
Rionegro, 054047
Research Site
Zipaquirá, 200251

Other trials in Colombia

Peru4 sites

Research Site
Lima, 15036
Research Site
Lima, 15046
Research Site
Lima, 15088
Research Site
Lima, LIMA 21

Other trials in Peru

Philippines3 sites

Research Site
Baguio City, 2600
Research Site
Cebu City, 6000
Research Site
Iloilo City, 5000

Other trials in Philippines

Russia2 sites

Research Site
Penza, 440067
Research Site
Saratov, 410012

Other trials in Russia

Puerto Rico1 site

Research Site
Ponce, 00717

Other trials in Puerto Rico

About this study

Official title: A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (TITANIA)

The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the previous 12 months. Participants should be receiving optimised treatment with maintenance inhaled therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) in stable doses throughout at least 3 months prior to enrolment.

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: Tozorakimab, Placebo
Keywords: Chronic Obstructive Pulmonary Disease, COPD, tozorakimab, exacerbations, ICS, LABA/LAMA
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TozorakimabDrug
Administered subcutaneously tozorakimab Dose 1 and placebo through Week 52.
TozorakimabDrug
Administered subcutaneously tozorakimab Dose 2 through Week 52.
PlaceboDrug
Placebo administered subcutaneously, equivalent volume to tozorakimab through week 52.

Study groups in NCT05158387
Study group	Role	What they receive
Tozorakimab Dose 1	Experimental	Dosing subcutaneously tozorakimab Dose 1 and placebo Receives: Drug: Tozorakimab
Tozorakimab Dose 2	Experimental	Dosing subcutaneously tozorakimab Dose 2 Receives: Drug: Tozorakimab
Placebo	Placebo comparator	Dosing subcutaneously with equivalent volume to tozorakimab Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.
The primary endpoint will be assessed first in the primary population (former smokers with symptomatic COPD and a history of exacerbations, on optimised treatment with maintenance inhaled therapy [triple therapy, or dual therapy if triple is not considered appropriate]) and then assessed in the overall population of participants.
Measured: over 52 weeks

Secondary outcomes (21)

Annualized rate of moderate to severe COPD exacerbations in former or current smokers.
The annualized rate will be assessed in the overall population of participants including current and former smokers with symptomatic COPD and history of exacerbations, on optimised treatment with maintenance inhaled therapy.
Measured: over 52 weeks
Time to first moderate to severe COPD exacerbation in former smokers.
To explore the extent to which treatment with each dose of tozorakimab delays the time to first exacerbation compared with placebo in former smokers.
Measured: over 52 weeks
Mean change from baseline in pre-BD, pre-dose trough FEV1 (mL) in former smokers.
Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former smokers.
Measured: Week 52, or over 52 weeks
Mean change from baseline in pre-BD, pre-dose trough FEV1 (mL) in the overall population of current and former smokers.
Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in the overall population of current and former smokers.
Measured: Week 52, or over 52 weeks
Percentage of responders achieving MCID in E-RS:COPD total score in former smokers
Responder analyses for E-RS:COPD total score at Week 52 based upon a ≥ 2 point improvement (decrease) from baseline in former smokers.
Measured: Week 52
Percentage of responders achieving MCID in E-RS:COPD total score in the overall population of current and former smokers.
Responder analyses for E-RS:COPD total score at Week 52 based upon a ≥ 2 point improvement (decrease) from baseline in the overall population of current and former smokers.
Measured: Week 52
Mean change from baseline in E-RS:COPD total score in former smokers.
Difference in mean change in E-RS:COPD total score from baseline in former smokers.
Measured: over 52 weeks
Mean change from baseline in E-RS:COPD total score in the overall population of current and former smokers.
Difference in mean change in E-RS:COPD total score from baseline in the overall population of current and former smokers.
Measured: over 52 weeks
Percentage of responders achieving MCID in SGRQ total score in former smokers.
Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline in former smokers.
Measured: Week 52
Percentage of responders achieving MCID in SGRQ total score in the overall population of current and former smokers.
Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline in the overall population of current and former smokers.
Measured: Week 52
Mean change from baseline in SGRQ total score from in former smokers.
Difference in mean change from baseline in SGRQ total score in former smokers.
Measured: over 52 weeks
Mean change from baseline in SGRQ total score from in the overall population of current and former smokers.
Difference in mean change from baseline in SGRQ total score in the overall population of current and former smokers.
Measured: over 52 weeks
Time to first severe COPD exacerbation in former smokers.
To evaluate hazard ratio of first severe COPD exacerbation in former smokers.
Measured: over 52 weeks
Annualized rate of severe COPD exacerbations in former smokers.
The rate ratio of severe COPD exacerbations will be assessed in former smokers.
Measured: over 52 weeks
Change from baseline in CAT total score.
Analyses of change from baseline in CAT total score in former smokers.
Measured: Week 52
Percentage of participants with a decrease in CAT total score in former smokers.
Proportion of participants achieving MCID in CAT total score, a decrease in CAT total score of ≥ 2 points from baseline in former smokers.
Measured: Week 52
Proportion of participants having ≥ 1 healthcare resource utilization type in former smokers.
Proportion of participants having ≥ 1 healthcare resource utilization type in former smokers.
Measured: over 52 weeks
Annualized rate of healthcare resource utilization in former smokers.
Annualized rate of healthcare resource utilization in former smokers.
Measured: over 52 weeks
The change from baseline in mean number of puffs per day in rescue use in former smokers.
Difference in mean number of puffs per day from baseline.
Measured: over 52 weeks
Trough serum concentrations of tozorakimab.
Pharmacokinetics: concentrations of tozorakimab in trough serum.
Measured: over 52 weeks
Presence of anti-drug antibodies.
Immunogenicity: presence of tozorakimab anti-drug antibodies in blood serum.
Measured: over 60 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Feb 202222 Mar 2026

First posted15 Dec 2021
Study start7 Feb 2022
Primary completion19 Jan 2026
Study completion22 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 1,172 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05158387
Sponsor's protocol ID: D9180C00004
Other IDs: 2021-003771-34
Acronym: TITANIA
Status last verified: Apr 2026
First submitted: 2 Dec 2021
Last updated: 16 Apr 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Sciurba FC, Watz H, Bourdin A, Janssens W, Martinez FJ, Zheng J, van den Berge M, Bonini M, Han MK, Singh D, Criner GJ, Brightling CE, Papi A, Bhatt SP, Jenkins M, Mikosz M, Cholbinski P, Ziemiecka M, Lofdahl M, Arya D, Yadavalli M, Brodek BH, Fageras M, Bardsley S, Martin N, Patel R, Psallidas I; OBERON and TITANIA Trial Investigators. Tozorakimab to Prevent COPD Exacerbations. N Engl J Med. 2026 Sep 8. doi: 10.1056/NEJMoa2606998. Online ahead of print.
PubMed 42708515
Watz H, Sciurba FC, Bonini M, Yanez A, Bourdin A, Zheng J, De Soyza A, Janssens W, van den Berge M, Xu JF, Saraiva GL, Jenkins M, Jimenez E, Lofdahl M, Li J, Mikosz M, Kishishita N, Jackson S, Johnson S, Patel R, Fageras M, Psallidas I. Phase III LUNA clinical programme: design of four randomised, double-blind, placebo-controlled studies assessing the efficacy and safety of tozorakimab in patients with symptomatic COPD and a high risk of exacerbations. BMJ Open Respir Res. 2026 Jul 20;13(1):e004145. doi: 10.1136/bmjresp-2026-004145.
PubMed 42476723

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (TITANIA)
ClinicalTrials.gov ID: NCT05158387
Acronym / sponsor ID: TITANIA / D9180C00004
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease, COPD, tozorakimab, exacerbations, ICS, LABA/LAMA
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,172 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 7 Feb 2022 (actual)
Primary completion: 19 Jan 2026 (actual)
Study completion: 22 Mar 2026 (actual)
First posted: 15 Dec 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Tozorakimab Dose 1	Experimental	Drug: TozorakimabDosing subcutaneously tozorakimab Dose 1 and placebo
Tozorakimab Dose 2	Experimental	Drug: TozorakimabDosing subcutaneously tozorakimab Dose 2
Placebo	Placebo comparator	Drug: PlaceboDosing subcutaneously with equivalent volume to tozorakimab

Who may qualify

Ages: 40 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Participant must be ≥ 40 years of age and capable of giving signed informed consent.
Documented diagnosis of COPD for at least one year prior to enrolment.
Post BD FEV1/FVC < 0.70 and post-BD FEV1 >20% of predicted normal value.
Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
Documented optimized inhaled dual or triple therapy at a stable dose for at least 3 months prior to enrolment.

Key exclusion criteria (18 listed)

Clinically important pulmonary disease other than COPD.
Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms.
Current diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18.
Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment that could affect safety, study findings or participants ability to complete the study.
COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TozorakimabAdministered subcutaneously tozorakimab Dose 1 and placebo through Week 52.	Drug	Tozorakimab Dose 1
TozorakimabAdministered subcutaneously tozorakimab Dose 2 through Week 52.	Drug	Tozorakimab Dose 2
PlaceboPlacebo administered subcutaneously, equivalent volume to tozorakimab through week 52.	Drug	Placebo

Primary outcome

Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.
Time frame: over 52 weeks
The primary endpoint will be assessed first in the primary population (former smokers with symptomatic COPD and a history of exacerbations, on optimised treatment with maintenance inhaled therapy [triple therapy, or dual therapy if triple is not considered appropriate]) and then assessed in the overall population of participants.

21 secondary outcomes

Annualized rate of moderate to severe COPD exacerbations in former or current smokers.
Time frame: over 52 weeks
Time to first moderate to severe COPD exacerbation in former smokers.
Time frame: over 52 weeks
Mean change from baseline in pre-BD, pre-dose trough FEV1 (mL) in former smokers.
Time frame: Week 52, or over 52 weeks
Mean change from baseline in pre-BD, pre-dose trough FEV1 (mL) in the overall population of current and former smokers.
Time frame: Week 52, or over 52 weeks
Percentage of responders achieving MCID in E-RS:COPD total score in former smokers
Time frame: Week 52
Percentage of responders achieving MCID in E-RS:COPD total score in the overall population of current and former smokers.
Time frame: Week 52
Mean change from baseline in E-RS:COPD total score in former smokers.
Time frame: over 52 weeks
Mean change from baseline in E-RS:COPD total score in the overall population of current and former smokers.
Time frame: over 52 weeks
Percentage of responders achieving MCID in SGRQ total score in former smokers.
Time frame: Week 52
Percentage of responders achieving MCID in SGRQ total score in the overall population of current and former smokers.
Time frame: Week 52
Mean change from baseline in SGRQ total score from in former smokers.
Time frame: over 52 weeks
Mean change from baseline in SGRQ total score from in the overall population of current and former smokers.
Time frame: over 52 weeks
Time to first severe COPD exacerbation in former smokers.
Time frame: over 52 weeks
Annualized rate of severe COPD exacerbations in former smokers.
Time frame: over 52 weeks
Change from baseline in CAT total score.
Time frame: Week 52
Percentage of participants with a decrease in CAT total score in former smokers.
Time frame: Week 52
Proportion of participants having ≥ 1 healthcare resource utilization type in former smokers.
Time frame: over 52 weeks
Annualized rate of healthcare resource utilization in former smokers.
Time frame: over 52 weeks
The change from baseline in mean number of puffs per day in rescue use in former smokers.
Time frame: over 52 weeks
Trough serum concentrations of tozorakimab.
Time frame: over 52 weeks
Presence of anti-drug antibodies.
Time frame: over 60 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
Derived from this study: PubMed 42708515Sciurba FC, Watz H, Bourdin A, Janssens W, Martinez FJ, Zheng J, van den Berge M, Bonini M, Han MK, Singh D, Criner GJ, Brightling CE, Papi A, Bhatt SP, Jenkins M, Mikosz M, Cholbinski P, Ziemiecka M, Lofdahl M, Arya D, Yadavalli M, Brodek BH, Fageras M, Bardsley S, Martin N, Patel R, Psallidas I; OBERON and TITANIA Trial Investigators. Tozorakimab to Prevent COPD Exacerbations. N Engl J Med. 2026 Sep 8. doi: 10.1056/NEJMoa2606998. Online ahead of print.
Derived from this study: PubMed 42476723Watz H, Sciurba FC, Bonini M, Yanez A, Bourdin A, Zheng J, De Soyza A, Janssens W, van den Berge M, Xu JF, Saraiva GL, Jenkins M, Jimenez E, Lofdahl M, Li J, Mikosz M, Kishishita N, Jackson S, Johnson S, Patel R, Fageras M, Psallidas I. Phase III LUNA clinical programme: design of four randomised, double-blind, placebo-controlled studies assessing the efficacy and safety of tozorakimab in patients with symptomatic COPD and a high risk of exacerbations. BMJ Open Respir Res. 2026 Jul 20;13(1):e004145. doi: 10.1136/bmjresp-2026-004145.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

212 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tozorakimab in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 212 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 212 sites in China, United States, Poland, Italy, Brazil and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers. (time frame: over 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05158387, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.